FDA.reportPublic FDA data

Brace Relief

Product NDC
60306-115
11-digit product format
603060115
Labeler code
60306
Product ID
60306-115_c4d6e935-9aaa-430e-ae72-51d4c84fcbf4
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
ORAL
Labeler
InfaLab,Inc
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-01-03
Substance
BENZOCAINE
Active strength
9 mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct60306-115IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage60306-11560306-115-05IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Brace Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE9 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1547591Internal RxNorm lookup
1547593Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d7e57d67-4234-44a9-bbd3-72e99cd5bdb3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60306-115-052022-04-11C16284748780-19855e2a2-3c21-60a7-e053-dbdaa90a05bdd7e57d67-4234-44a9-bbd3-72e99cd5bdb3
60306-115-052019-12-13C16284748780-19855e2a2-3c21-60a7-e053-dbdaa90a05bdd7e57d67-4234-44a9-bbd3-72e99cd5bdb3
60306-115-052019-11-27C16284748780-19855e2a2-3c21-60a7-e053-dbdaa90a05bdd7e57d67-4234-44a9-bbd3-72e99cd5bdb3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60306-115-05Brace Relief0.3 mL in 1 TUBEGEL0.312

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
BenzocaineACTIVE MOIETYU3RSY48JW5BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
Clove OilINACTIVE INGREDIENT578389D6D0BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
MentholINACTIVE INGREDIENTL7T10EIP3ABRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
Methyl SalicylateINACTIVE INGREDIENTLAV5U5022YBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
MyrrhINACTIVE INGREDIENTJC71GJ1F3LBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
Peppermint OilINACTIVE INGREDIENTAV092KU4JHBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
PhenolINACTIVE INGREDIENT339NCG44TVBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
Polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60306-115BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]11Current NDC, Legacy NDC, 1 package rows20241010_d7e57d67-4234-44a9-bbd3-72e99cd5bdb3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 18 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Major Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFATMajor Pharmaceuticalsa6cc3fbc-6302-4033-e053-2a95a90a19f02024-09-11WarningsExact identifier
application number: M004
Leader Triple antibioticBACITRACIN,NEOMYCIN,POLYMXINCardinal Health 110 dba LEADER2175e00a-bf85-3377-e063-6394a90a916f2024-09-06WarningsExact identifier
application number: M004
Members Mark Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BSam's West Inc200f4020-7699-4a9e-8fab-2d3df9e768362024-09-05WarningsExact identifier
application number: M004
Leader Poly BacitracinBACITRACIN ZINC POLYMIXIN B SULFATECardinal Health 110 dba LEADER20d7624f-cafa-25e1-e063-6394a90a44392024-08-29WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BMeijer Distribution Incedcb423e-b5c2-4e26-8f7f-9b9ee575042c2024-08-19WarningsExact identifier
application number: M004
Major ClotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals,Inc.562dfc9f-1897-330a-e054-00144ff8d46c2024-08-14WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWildeman Business Group1f96450a-3bda-1f0a-e063-6294a90a514f2024-08-13WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEProvision Medicalbbf4b99c-9738-4855-82a6-f4e213924ec92024-08-09WarningsExact identifier
application number: M004
Tetracyte Topical Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC4ac5177d-bb67-45e6-adcf-44f0821746bd2024-08-01WarningsExact identifier
application number: M004
BacitracinBACITRACINPadagis Israel Pharmaceuticals Ltdbebbedf6-dd65-47a4-aa3e-ad197b3e05a12024-07-31WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCChain Drug Marketing Association Inc.1cd9ded3-068c-496e-e063-6394a90a6a0b2024-07-09WarningsExact identifier
application number: M004
Anti-Itch with AloeHYDROCORTISONE 1%Chain Drug Marketing Association Inc.1cbea7cd-03a0-1469-e063-6294a90a7cc12024-07-08WarningsExact identifier
application number: M004
astonea First AidBACITRACIN ZINCASTONEA LABS PRIVATE LIMITEDde0b2e06-64bc-78f0-e053-2995a90a39a02024-06-25WarningsExact identifier
application number: M004
Publix Bacitracin ZincBACITRACIN ZINCPUBLIX SUPER MARKETS, INC.51f21123-7826-40c9-b2aa-b202125085e22024-06-17WarningsExact identifier
application number: M004
Publix Triple AntibioticBACITRACIN ZINC 400 U, POLYMXYIN B SULFATE 5,000 U, NEOMYCIN SULFATE 3.5MG/GPUBLIX SUPER MARKETS, INC.871fa43c-a1be-4c15-bbfa-a998a2d89d2e2024-06-17WarningsExact identifier
application number: M004
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMNuCare Pharmaceuticals,Inc.66ff9726-20da-688a-e053-2a91aa0a59ac2024-06-06WarningsExact identifier
application number: M004
QC Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.Chain Drug Marketing Association1a1501a4-75b0-5900-e063-6394a90ad77a2024-06-04WarningsExact identifier
application number: M004
Always Save Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLC1a00df31-a38a-fc82-e063-6394a90abbf32024-06-03WarningsExact identifier
application number: M004
PENTREXCILINA TRIPLE ANTIBIOTIC PLUS PAIN RELIEFBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINEOPMX LLC7c0d3cdf-af50-4a65-a01b-a33510feeb942024-05-17WarningsExact identifier
application number: M004
PENIMIXCINABACITRACIN, NEOMYCIN SULFATE, POLYMIXIN B SULFATE, PRAMOXINE HYDROCHLORIDEOPMX LLC92bcbc02-9683-4117-af2b-6d4687796f1f2024-05-17WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1547591benzocaine 9 % Oral GelPSNd7e57d67-4234-44a9-bbd3-72e99cd5bdb312
1547593Brace Relief 9 % Oral GelPSNd7e57d67-4234-44a9-bbd3-72e99cd5bdb312
1547593benzocaine 0.09 MG/MG Oral Gel [Brace Relief]SBDd7e57d67-4234-44a9-bbd3-72e99cd5bdb312
1547591benzocaine 0.09 MG/MG Oral GelSCDd7e57d67-4234-44a9-bbd3-72e99cd5bdb312
1547591benzocaine 9 % Oral GelSYd7e57d67-4234-44a9-bbd3-72e99cd5bdb312
1547593Brace Relief 0.09 MG/MG Oral GelSYd7e57d67-4234-44a9-bbd3-72e99cd5bdb312
1547593Brace Relief 9 % Oral GelSYd7e57d67-4234-44a9-bbd3-72e99cd5bdb312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60306-115-0560306011505.3 mL in 1 TUBE (60306-115-05) 2005-01-030000-00-00NoNoCurrent